Browsing Tag
US Food and Drug Administration
348 posts
ProTom Radiance 330 proton therapy system bags FDA 510(k) Clearance
ProTom International has been given 510(k) clearance from the US Food and Drug Administration (FDA) for its Radiance…
October 8, 2019
Verastem gets FDA orphan drug status for COPIKTRA for T-Cell lymphoma
Verastem Oncology has secured orphan drug designation for COPIKTRA (duvelisib), an oral inhibitor of phosphoinositide 3-kinase (PI3K), from…
October 7, 2019
Sound Pharmaceuticals bags FDA fast track status for SPI-1005 in Meniere’s Disease
US biopharma company Sound Pharmaceuticals said that its investigational drug SPI-1005 has secured the fast track designation (FTD)…
September 18, 2019
Dynacure’s centronuclear myopathies drug DYN101 gets FDA orphan drug designation
French pharma company Dynacure has secured orphan drug designation for its investigational antisense drug DYN101 from the US…
August 10, 2019
Stokes’ STK-001 secures FDA orphan drug designation for Dravet Syndrome
US biotech company Stoke Therapeutics has secured orphan drug designation for its lead product candidate – STK-001 from…
August 7, 2019
Celgene bags Otezla FDA approval for oral ulcers in Behcet’s Disease
Otezla FDA approval : US biotech company Celgene has bagged approval from the US Food and Drug Administration…
July 21, 2019
Sensorion gets FDA nod for SENS-401 trial for inner ear condition
French inner ear diseases company Sensorion has secured the investigational new drug (IND) clearance from the US Food…
July 13, 2019
Eli Lilly’s Emgality gets FDA green light for migraine prevention
Eli Lilly and Company has secured approval from the US Food and Drug Administration (FDA) for its migraine…
September 29, 2018